Clinical trials: Lipid Metabolism Disorders
Hypercholesterolemia
Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151)
The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.
- Trial name
- NCT00652444
- Testing
- ezetimibe, simvastatin
- Volunteers
- 120 people
- Sponsor
- Organon and Co
Fabry Disease
Fabry Outcome Survey (FOS)
The purpose of this study is to collect data that will increase understanding of Fabry disease history and progression, in treated and untreated patients with Fabry disease.
- Trial name
- FOS (NCT03289065)
- Where
- United States
- Volunteers
- 4,000 people
- Sponsor
- Shire
Dyslipidemia
Evaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312
The purpose of this study is to Evaluation of absorption, metabolism, and excretion of [14C]-K-312 and estimation of the absolute bioavailability of K-312 in healthy male subjects
- Trial name
- NCT02676830
- Testing
- K-312 100 mg, K-312 100 ug C14 IV
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Kowa Research Institute, Inc.
Heterozygous Familial Hypercholesterolemia, Premature Coronary Heart Disease
A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery Disease
VT-10201 is an Open-label, Phase 1b, Single-ascending Dose Study That Will Evaluate the Safety of VERVE-102 Administered to Patients With Heterozygous Familial Hypercholesterolemia (HeFH) or Premature Coronary Artery Disease…
- Trial name
- NCT06164730
- Testing
- VERVE-102
- Where
- 27 sites in United States, Australia and 4 more
- Volunteers
- 85 people
- Sponsor
- Verve Therapeutics, Inc.
GM2 Gangliosidosis, Niemann-Pick Type C Disease
A Study to Evaluate the Safety and Efficacy of Nizubaglustat (AZ-3102) in Patients With GM2 Gangliosidosis or Niemann-Pick Type C Disease
This open-label study aims to gather long-term safety, tolerability, PK, biomarker, and clinical efficacy data relating to daily administration of Nizubaglustat in participants previously enrolled in the Phase 2 RAINBOW study…
- Trial name
- PRISMA (NCT07399704)
- Testing
- AZ-3102
- Where
- 3 sites in Brazil
- Volunteers
- 21 people
- Sponsor
- Azafaros B.V.
Hypercholesterolemia, Atherosclerotic Cardiovascular Diseases
Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)
The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current…
- Trial name
- NCT02666664
- Testing
- ETC-1002
- Where
- 104 sites in United States, Canada and 4 more
- Volunteers
- 2,230 people
- Sponsor
- Esperion Therapeutics, Inc.
Hypercholesterolaemia
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
Primary Objective: To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) and every 4 weeks (Q4W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels…
- Trial name
- NCT03510884
- Testing
- Alirocumab SAR236553 (REGN727), Rosuvastatin, Atorvastatin
- Where
- 43 sites in United States, Argentina and 22 more
- Volunteers
- 153 people
- Sponsor
- Sanofi
Body Fat Disorder
Fat Reduction in the Submandibular/Submental Area
The purpose of this study is to further evaluate the safety and efficacy of non-invasive reduction of subcutaneous fat in the submental and submandibular area using Cryolipolysis.
- Trial name
- NCT02700165
- Testing
- The ZELTIQ CoolSculpting System
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Zeltiq Aesthetics
Dyslipidemia (Fredrickson Type Ⅱa), Dyslipidemia (Fredrickson Type Ⅱb)
CKD-337 Drug Interaction Study
The purpose of this study is to evaluate a pharmacokinetic drug interaction between atorvastatin and fenofibrate in healthy subjects.
- Trial name
- NCT02066207
- Testing
- Fenofibrate, Atorvastatin
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Obesity
A Study on Efficacy and Safety of Topiramate in Maintaining Weight Loss in Obese Patients Following an Intensive, Non-Pharmacologic Weight Loss Program
The purpose of this study is to compare the efficacy and safety of topiramate 96mg and 192mg daily) with placebo in the treatment of obesity following an intensive non-pharmacologic weight loss program.
- Trial name
- NCT00236600
- Testing
- topiramate
- Volunteers
- 561 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Hypercholesterolemia
Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia (P05456)
Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and atorvastatin in participants with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with…
- Trial name
- NCT00654095
- Testing
- Ezetimibe, atorvastatin
- Volunteers
- 146 people
- Sponsor
- Organon and Co
Diabetes Mellitus
Safety Study of TAK-559 in Treating Subjects With Type 2 Diabetes Mellitus
The purpose of this study was to determine the long-term safety of TAK-559, once daily (QD), in subjects with Type 2 Diabetes.
- Trial name
- NCT00762112
- Testing
- TAK-559
- Volunteers
- 316 people
- Sponsor
- Takeda
Neuronal Ceroid Lipofuscinosis CLN5
Gene Therapy Study for Children With CLN5 Batten Disease
This is a prospective, non-randomized, open-label, dose escalation study of a single administration of gene therapy in children who are 3 to 9 years old with Neuronal Ceroid Lipofuscinosis (Batten) Subtype 5 (CLN5) disease.
- Trial name
- CLN5-200 (NCT05228145)
- Testing
- NGN-101
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 6 people
- Sponsor
- Neurogene Inc.
Familial Hypercholesterolemia
A Study to Determine the Safety, Tolerability, and Efficacy of SHR-1209 in Patients With Familial Hypercholesterolemia
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1209 in subjects with familial hypercholesterolemia.
- Trial name
- NCT04455581
- Testing
- SHR-1209
- Volunteers
- 8 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hypercholesterolemia
Efficacy of Lapaquistat Acetate in Subjects With Hypercholesterolemia
The purpose of this study is to determine the role of time of dosing on the lipid-lowering effects of lapaquistat acetate, once daily (QD) or twice daily (BID), in subjects with hypercholesterolemia.
- Trial name
- NCT00865228
- Testing
- Lapaquistat acetate
- Where
- 22 sites in United States
- Volunteers
- 224 people
- Sponsor
- Takeda
Hypercholesterolemia
Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients
The purpose of this research study is to see how ETC-1002 is tolerated in the body, to measure the amount of ETC-1002 in the blood, and to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other…
- Trial name
- NCT01941836
- Testing
- ETC-1002, Ezetimibe
- Where
- 68 sites in United States
- Volunteers
- 349 people
- Sponsor
- Esperion Therapeutics, Inc.
Dyslipidemia
A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029)
This study will investigate the effect of MK0859 when administered alone and when in combination with atorvastatin in lowering Low Density Lipoprotein -Cholesterol (LDL-C) in Japanese patients with dyslipidemia.
- Trial name
- NCT00977288
- Testing
- anacetrapib, Comparator: atorvastatin
- Volunteers
- 408 people
- Sponsor
- Merck Sharp & Dohme LLC
Severe Familial Hypercholesterolemia
Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders
A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.
- Trial name
- TAUSSIG (NCT01624142)
- Testing
- Evolocumab
- Where
- 44 sites in United States, Australia and 16 more
- Volunteers
- 300 people
- Sponsor
- Amgen
Diabetes, Hyperlipidemias
The PK Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers.
A randomized, open-label, single dose, crossover study to compare the pharmacokinetic characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in healthy male volunteers.
- Trial name
- NCT03690778
- Testing
- "Metformin" and "Rosuvastatin" seperately, JLP-1310
- Where
- South Korea
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Jeil Pharmaceutical Co., Ltd.
Healthy
A Study Testing A Radioactive Compound Given Through A Vein With And Without The Non-Radioactive Compound, Given By Mouth, To Characterize Tissue Distribution Using Positron Emission Tomography Scanning
In this study, radioactive PF-06427878 will be administered, through a vein, alone and with 2 different oral doses of non-radioactive PF-06427878 to healthy, adult, male subjects.
- Trial name
- NCT02410525
- Testing
- [11C]PF-06427878, PF-06427878 10 mg, PF-06427878 600 mg
- Where
- 3 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer
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